G3P-01 is an investigational pectin extracted, enriched and purified from commercial squash puree intended for human consumption. Pectins are an important constituent of fruits and vegetables, and health benefits are attributed to its intake. Some of the health benefits of pectins are attributed to inhibition of galectin-3. This study investigates if 30-days of G3P-01 intake in individuals with elevated galectin-3 induces biomarker changes that can be attributed to target engagement. Participants will be randomized into four groups (placebo, 100mg, 250mg and 1000mg G3P-01).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
48
General Practitioners Research Institute
Groningen, Netherlands
To evaluate target engagement attributable to G3P-01 use in volunteers with elevated galectin-3 (≥ 16.0ng/mL)
Change from baseline of pathway markers consistent with galectin-3 inhibition (dose-response effect) measured by proteomics
Time frame: 4 months
To evaluate tolerability of G3P-01
Changes in the Gastrointestinal Symptom Rating Scale (1 means no symptoms, 7 means symptoms)
Time frame: 4 months
To evaluate tolerability of G3P-01
Number of participants with abnormal laboratory tests results
Time frame: 4 months
To evaluate tolerability of G3P-01
Number of participants with abnormal physical examination findings
Time frame: 4 months
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